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NCT Number: NCT06248684

Prevention of Postoperative Delirium in Elderly Patients

Prevention of Postoperative Delirium in the care of Elderly Patients. A Monocentric, Prospective Intervention Study With the Question of Whether the Incidence, Length and Severity of Postoperative Delirium Can be Reduced by Implementing a Standardised, Multidimensional Delirium Management Protocol.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Within the framework of a six-month observation period, the investigators intend to identify risk factors of the patient collective for the development of postoperative delirium. For this purpose, a preoperative risk assessment is performed, which includes cognitive and physical performance as well as premedication and concomitant diseases. Included are patients of at least 65 years of age of defined specialties. Postoperatively, patients who have undergone the assessment are tested for delirium once per shift until the third postoperative day and severity and duration are documented. After completion of the observation period, risk factors favoring the development of postoperative delirium will be identified. In the subsequent intervention period, patients from the age of 65 years with an additional identified risk factor will receive standardized, targeted perioperative care. This includes both adherence to preventive measures in accordance with guidelines and the recommendation of therapeutic measures if a delirium is diagnosed. Through the standardized, interprofessional and interdisciplinary application of the described approach, the investigator aim to reduce the incidence, duration and severity of postoperative delirium. Furthermore, the evaluation of the identification of the weighting of risk factors as well as the identification of risk factors by the tests performed, length of hospital stay, three-month mortality and daily living skills after three months. In addition, a baseline EEG (standardized awake EEG before initiation) is recorded in a subgroup to determine whether patients at risk for delirium can be identified and whether intraoperative EEG parameters support the delirium risk assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >= 65 Years
  • intervention in one of the following departments: general and visceral surgery, urology, vascular surgery, orthopedics, trauma surgery,
  • Written consent by patient or legal guardian

Exclusion criteria

  • Foreign language patients without interpreter
  • non-consenting patients without a legal representative

Treatment and study plan

standardized prevention and therapy measures

Other

Patients from the age of 65 years with an additional risk factor for postoperative delirium are assigned to a multidimensional standardized perioperative care protocol.

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: for three days postoperatively and if the patient is delirium positive on the last day for the period until he is delirium negative or discharged from inpatient care, up to the day 90 visit at the latest

    Patients are examined once per shift for the described duration postoperatively using validated tests for delirium (CAM-ICU or 3D-CAM). Delirium testing is supplemented by pain assessment using the numerical rating scale (NRS).

Secondary outcomes

  1. duration of postoperative delirium

    Time frame: for three days postoperatively and if the patient has delirium on the last day for the period until he is delirium negative or discharged from inpatient care, up to the day 90 visit at the latest

    Patients are examined once per shift for the described duration postoperatively using validated tests for delirium (CAM-ICU or 3D-CAM). Delirium testing is supplemented by pain assessment using the numerical rating scale (NRS).

  2. Severity of the postoperative delirium

    Time frame: for three days postoperatively and if the patient has delirium on the last day for the period until he is delirium negative or discharged from inpatient care, up to the day 90 visit at the latest

    Patients are examined once per shift for the described duration postoperatively using validated tests for delirium severity (CAM-ICU or 3D-CAM). Delirium testing is supplemented by pain assessment using the numerical rating scale (NRS).

  3. Which parameters and tests detect patients at risk for postoperative delirium?

    Time frame: From the time of premedication until three days postoperatively

    analysis of the preoperative risk assessment, perioperative clinical parameters and postoperative delirium screening.

  4. Can baseline and intraoperative EEG parameters be used to identify patients at risk? Does intraoperative burst suppression EEG represent a risk factor for delirium?

    Time frame: From the patient's arrival in the operating room to three days postoperatively

    Analysis of EEG data recorded immediately before induction of anesthesia and during surgery.

  5. When is the diagnosis of postoperative delirium most commonly made?

    Time frame: for three days postoperative

    Patients are examined once per shift for the described duration postoperatively using validated tests for delirium (CAM-ICU or 3D-CAM). Delirium testing is supplemented by pain assessment using the numerical rating scale (NRS).

  6. The implementation of a delirium management protocol during the intervention period serves to improve the three-month outcome of patients at risk in terms of maintaining their autonomy or daily living skills.

    Time frame: One-time interview three months postoperatively

    Patients are asked about their daily living skills by telephone three months after their surgical procedure.

  7. Implementation of a delirium management protocol reduces the length of hospital stay of risk patients

    Time frame: from the date of hospitalisation to the date of discharge from hospital, up to the day 90 visit at the latest

    The length of inpatient stay of patients before and after implementation of standardized care is evaluated

  8. Implementation of a delirium management protocol reduces three-month mortality in high-risk patients

    Time frame: Query of the patients' death data three months postoperatively

    Three-month mortality of patients before and after implementation of standardized care is evaluated

Study contacts

Contact information is provided by the study sponsor or research team.

Gerhard Prof. Dr. med. Schneider, MD

CONTACT

[email protected]

+49-89-41404291

Stefanie PD Dr. med. Pilge, MD

CONTACT

[email protected]

+49-89-41404291

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Prevention of Postoperative Delirium in the Care of Elderly Patients. A Monocentric, Prospective Intervention Study

Acronym: PODproject

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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